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QUALITY AGREEMENTS: REGULATORY CONSIDERATIONS ǩ COMPLIMENTARY CONTENT
Standard Operating Procedure
Quality Agreements:
Regulatory Considerations For
Development and Implementation
Contains:
Quality Agreements: Regulatory Considerations
For Development and Implementation
© COPYRIGHT 2009 ENKAP
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Standard Operating Procedure
Quality Agreements:
Regulatory Considerations For
Development and Implementation
Standard Operating Procedure
Quality Agreements: Regulatory Considerations For Development and Implementation
Table of Contents
1.0 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3.0 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.0 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6.0 History of Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.0 Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
8.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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Standard Operating Procedure
Quality Agreements: Regulatory Considerations For Development and Implementation
STANDARD OPERATING PROCEDURE
Title:
Quality Agreements: Regulatory Considerations
For Development and Implementation
SOP #:
300-003
Process Owner:
Effective Date:
Review Date:
Designation:
Name, Title
Date
Originator
Name, Title
Date
Unit Head Approval
Name, Title
Date
Quality Assurance Approval
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Standard Operating Procedure
enKap
Quality Agreements: Regulatory Considerations For Development and Implementation
Standard Operating Procedure
Quality Agreements
SOP No: 300-003
Page 2 of 5
Date:
1.0 Purpose
To provide standards for content and process used in the development and approval of a Quality Agreement
with Contract Manufacturing Organizations.
2.0 Scope
This procedure applies to Good Manufacturing Practice (GMP) operational departments and to the Quality
Assurance department.
3.0 Key Terms
TERM
DEFINITION
CMO
Contract Manufacturing Organization.
GMP
Good Manufacturing Practice.
Quality Agreement
A formal quality assurance approved document that outlines the quality
roles and responsibilities between contracting company and its approved
CMO or CRO for a GXP operational activity.
Vendor (Supplier)
A firm or person engaged in providing development or commercially
oriented products or services to contracting company.
Vendor (Supplier)
Assessment
A planned and systematic evaluation to determine the acceptability and
suitability of a potential or current vendor.
4.0 Responsibilities
ROLE
RESPONSIBILITY
GMP Operational
Department
Assist in development, review and approve the Quality Agreement.
Quality Assurance
Department
Issue the draft quality agreement to the operational and legal department
for comment and contractual alignment, and provide final approval of the
quality agreement.
Legal Department
Review the draft quality agreement for comment and contractual alignment.
Effective Date: ___________________
2
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Standard Operating Procedure
Quality Agreements: Regulatory Considerations For Development and Implementation
SOP No: 300-003
Page 3 of 5
Date:
Standard Operating Procedure
enKap
Quality Agreements
5.0 Procedure
PROCEDURE
ACTION
5.1
DEVELOPMENT OF QUALITY AGREEMENT
RESPONSIBILITY
Using the Quality Agreement template (refer to
attachments 1 and 2), design the Quality Agreement
to include, but not limited to, the following subjects:
• Responsibility of the Quality Agreement
• Provision for Amendment Requirements of the
Quality Agreement
• Definition of the Service Being Provided by the
CMO and/or Vendor (Supplier)
• Information Sharing Requirements
• Right to Audit
• Notification of Regulatory Agency Inspections
• Applicable Safety Requirements
• Service or Supply Requirements
5.1.1
• Testing and Release Requirements
• Quality Roles Between Contracting Company and
its Approved CMO Quality Operational Groups
GMP Operational
Department and Quality
Assurance Department
• Notification of Change
• Notification of Recall/Product Retrieval
• Notification of Deviations and Related Investigations
to Procedures
• System and/or Equipment Qualification and
Validation Requirements
• Storage and Control Documents
• Storage and Shipping of Product
• Revision Log
• Approvals
• Deliverable Acceptance/Rejection Criteria
Effective Date: ___________________
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Standard Operating Procedure
Quality Agreements: Regulatory Considerations For Development and Implementation
SOP No: 300-003
Page 4 of 5
Date:
Standard Operating Procedure
enKap
Quality Agreements
PROCEDURE
ACTION
5.2
DETERMINATION OF NEED FOR QUALITY
AGREEMENT
RESPONSIBILITY
The need for a Quality Agreement with a vendor or
supplier will be determined by, but not limited to, the
following criteria:
5.2.1
GMP Operational
Department and Quality
Assurance Department
• Results of vendor or supplier assessment
• Criticality of vendor or supplier to operational
requirements
• Clinical development phase
• Commercial production use
5.3
REVIEW OF QUALITY AGREEMENT
5.3.1
Conduct a review of the Quality Agreement for
potential liability and business contract conflict.
Legal Department
5.3.2
Conduct a review of the Quality Agreement to ensure
all required sections are included that pertain to the
actual services being provided by the CMO.
GMP Operational
Department
5.4
APPROVAL AND ISSUANCE
5.4.1
After completion and final review of the Quality
Agreement, the responsible GMP operational
department initiating the service with the CMO
or vendor, Quality Assurance Department
representatives, and the CMO and/or vendor quality
and management personnel approve the agreement
by signature and date. The Quality Agreement may
be a standalone document or incorporated into the
business agreement.
GMP Operational
Department and Quality
Assurance Department
5.4.2
After approval, provide a control copy of the signed
quality agreement to the CMO and/or vendor.
Quality Assurance
Department
Effective Date: ___________________
4
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Standard Operating Procedure
Quality Agreements: Regulatory Considerations For Development and Implementation
SOP No: 300-003
Page 5 of 5
Date:
Standard Operating Procedure
enKap
Quality Agreements
PROCEDURE
ACTION
RESPONSIBILITY
5.5
TRAINING
5.5.1
Applicable GMP Operational department personnel
are required to review the approved Quality
Agreement, as required, in order to become familiar
with the relevant sections of the agreement, and the
roles and responsibilities that have been agreed to
between the company and its approved CMO and/or
vendor.
5.6
MAINTENANCE
5.6.1
As required, the approved Quality Agreement is
amended to document changes in the roles and
responsibilities between the company and its
approved CMO and/or vendor.
Designated Personnel
GMP Operational
Department and Quality
Assurance Department
6.0 History of Change
SOP / REVISION NO.
DESCRIPTION OF SOP/REVISION
DATE
400-001
Quality Agreements
New
7.0 Attachments
Attachment 1:
Active Pharmaceutical Product Quality Agreement Template (Example)
8.0 References
Reference 1:
21 CFR 211.22(a)
To link to the references listed above, as well as additional references,
please visit our website: www.enKap.com
Effective Date: ___________________
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Now that you have reviewed the Quality
Agreement SOP, enKap is proud to present the
Quality Agreement Integrated Training and
Auditing Information Package
INSTRUCTIONAL GUIDE: QUALITY AGREEMENTS:
REGULATORY CONSIDERATIONS FOR DEVELOPMENT AND IMPLEMENTATION
This instructional guide explains what a quality agreement is, presents the regulatory basis for
quality agreements discusses design characteristics and enforcement strategies.
ACTIVE PHARMACEUTICAL INGREDIENT (API) PRODUCT QUALITY AGREEMENT
TEMPLATE-EXAMPLE
This template example joint agreement covers the essential quality attributes pertinent to
the manufacture of drug substance, describes the roles and responsibilities and the defined
process of communication between the Contracting Company and Contract Manufacturing
Organization (CMO) company.
QUALITY AGREEMENT SOP
This SOP provides standards for content and process used in the development and approval of a
Quality Agreement with Contract Manufacturing Organizations (CMO).
QUALITY AGREEMENT POWERPOINT TRAINING SLIDES
AND TRAINER INSTRUCTIONAL NOTES
Excellent training material that can be customized to your individual company’s information
needs.
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